MAUDE Adverse Event Report: SYNTHES MONUMENT 2.4MM DRILL BIT/QC WITH 65MM STOP; BIT, DRILL

Catalog Number 388.394

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Part 388.394, lot u248407: release to warehouse date: august 02, 2016 and august 04, 2016.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported during a c3-t1 posterior cervical/thoracic fusion, the surgeon attempted to insert a 4.5 x 28mm synapse 4.0 screw after preparing the screw path.The screw became stuck halfway down the path and would not advance further nor would it back out due to the patient¿s bone density.The surgeon then had to lock a rod within the screw tulip in order to helicopter the stuck screw out.He was able to get the screw out without any adverse effects to the patient.Later in the case, the surgeon was preparing the final screw pathway using the 2.4mm drill bit and the drill bit broke due to the patient¿s bone density.There was a fifteen (15) minute delay in surgery.No fragments were generated.The surgery was completed successfully with no harm to the patient.Concomitant devices returned: bar (part unknown, lot unknown, quantity 1); titanium locking screw (part 04.614.508, lot h089521, quantity 1).This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

The manufacturing investigation results are as follows.The returned 2.4 mm drill bit with 65 mm stop, quick coupling, was examined and the complaint condition was able to be confirmed as the distal 9 mm was found to be broken and not returned.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned devices¿ lot numbers and no mrrs, ncrs or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition, device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.4MM DRILL BIT/QC WITH 65MM STOP
• Type of Device: BIT, DRILL
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6110240
• MDR Text Key: 60316776
• Report Number: 1719045-2016-10834
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 388.394
• Device Lot Number: U248407
• Other Device ID Number: (01)10705034740249(10)7411093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE (1) UNKNOWN BAR; ONE PART 04.614.508, LOT H089521, LOCKING SCREW
• Patient Age: 63 YR